NDA submitted for rivaroxaban for the treatment of non-valvular atrial fibrillation (AF)

Johnson & Johnson Pharmaceutical Research & Development announced that it has submitted a New Drug Application to the FDA for rivaroxaban for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). The submission is supported by data from the pivotal, global Phase 3 ROCKET AF (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) trial.

Rivaroxaban is a novel oral anticoagulant being evaluated for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role. In clinical studies, the compound has shown no requirement for routine laboratory coagulation monitoring, and limited risk for food and drug interactions.

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